LandmarkRCT

RE-SPECT CVT

Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis

JAMA Neurology, 2019 · Exploratory, prospective, randomized (1:1), open-label, multicenter trial with blinded end-point adjudication; 25 weeks of follow-up.

Clinical question

Is dabigatran as effective and safe as dose-adjusted warfarin for preventing recurrent venous thrombosis after cerebral venous thrombosis?

Population: 120 adults with acute cerebral venous thrombosis who were stable after 5 to 15 days of parenteral heparin, at 51 sites in 9 countries.
Inclusion criteria: Acute CVT, stable after 5 to 15 days of parenteral heparin.
CVT associated with central nervous system infection or major trauma was excluded; intracranial hemorrhage from the index CVT was allowed.
Intervention: Dabigatran 150 mg twice daily for 24 weeks (60 patients).
Comparator: Dose-adjusted warfarin for 24 weeks (60 patients).
Primary outcome: Composite of a new venous thromboembolic event (recurrent CVT, deep vein thrombosis, pulmonary embolism or splanchnic vein thrombosis) or major bleeding.
Secondary outcomes: Cerebral venous recanalization.
Clinically relevant non-major bleeding.
Result: No recurrent venous thromboembolism occurred in either arm; major bleeding was infrequent and similar. (Major bleeding 1 (1.7%) with dabigatran vs 2 (3.3%) with warfarin; recanalization 60.0% vs 67.3%.)

What the trial found

No recurrent venous thromboembolic events were seen in either group. One major bleed (intestinal) occurred on dabigatran and two (intracranial) on warfarin, with one further clinically relevant non-major bleed on warfarin. Recanalization occurred in 60.0% on dabigatran and 67.3% on warfarin.

Current guideline position

The 2024 AHA scientific statement on cerebral venous thrombosis discusses the evidence for anticoagulation. Initial heparin followed by an oral anticoagulant remains the standard approach.

Clinical interpretation

RE-SPECT CVT found both anticoagulants carried a low risk of recurrence and bleeding, supporting dabigatran as a reasonable alternative to warfarin after initial heparin in stable patients. Because it was small and exploratory, it cannot show equivalence on efficacy.

Limitations

Exploratory, small trial (120 patients); no recurrent events occurred, so efficacy could not be compared.
Open-label design, with blinded end-point adjudication.
Only patients stable after 5 to 15 days of heparin were enrolled.

Low certainty

Clinical Context & Relevant Topics (2)

Disease Reference

Acute Ischemic Stroke

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Intracranial Hemorrhage: ICH & SAH

Spontaneous ICH vs Aneurysmal SAH, INTERACT-2/ATACH-2 blood pressure targets, emergency anticoagulant reversal, ENRICH minimally invasive evacuation, ISAT coiling, and Nimodipine for delayed cerebral ischemia.

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